Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt


  • MeiLan K. Han
  • Gerard J. Criner
  • Mark T. Dransfield
  • David M. G. Halpin
  • Christine E. Jones
  • Sally Kilbride
  • Lange, Peter
  • Sally Lettis
  • David A. Lipson
  • David A. Lomas
  • Neil Martin
  • Fernando J. Martinez
  • Robert A. Wise
  • Ian P. Naya
  • Dave Singh

Introduction: Clinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes and the effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.

Methods: IMPACT was a phase III, double-blind, 52-week, multicentre trial. Patients with symptomatic COPD and at least one moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mu g, FF/VI 100/25 mu g or UMEC/VI 62.5/25 mu g. CID at the time-point of interest was defined as a moderate/severe exacerbation, >= 100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (increase of >= 4.0 units in St George's Respiratory Questionnaire total score or increase of >= 2.0 units in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to week 52 in patients with/without a CID by week 28. A prospective analysis evaluated time to first CID with each treatment.

Results: Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52 (all p

Conclusions: Prevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.

Tidsskrift ERJ Open Research
Udgave nummer1
Antal sider12
StatusUdgivet - 2021

ID: 261565792